Methocarbamol 500 MG Oral Tablet
WARNINGS
Since methocarbamol may possess a general CNS depressant effect, patients receiving methocarbamol tablets USP should be cautioned about combined effects with alcohol and other CNS depressants.
Safe use of methocarbamol tablets USP has not been established with regard to possible adverse effects upon fetal development.
There have been reports of fetal and congenital abnormalities following in utero exposure to methocarbamol.
Therefore, methocarbamol tablets USP should not be used in women who are or may become pregnant and particularly during early pregnancy unless in the judgment of the physician the potential benefits outweigh the possible hazards (see PRECAUTIONS, Pregnancy).(see PRECAUTIONSPRECAUTIONS, PregnancyPregnancy).
Use In Activities Requiring Mental Alertness Methocarbamol may impair mental and/or physical abilities required for performance of hazardous tasks, such as operating machinery or driving a motor vehicle.
Patients should be cautioned about operating machinery, including automobiles, until they are reasonably certain that methocarbamol therapy does not adversely affect their ability to engage in such activities.
DRUG INTERACTIONS
Drug Interactions See WARNINGS and PRECAUTIONS See WARNINGSWARNINGS and PRECAUTIONSPRECAUTIONS for interaction with CNS drugs and alcohol.
Methocarbamol may inhibit the effect of pyridostigmine bromide.
Therefore, methocarbamol should be used with caution in patients with myasthenia gravis receiving anticholinesterase agents.
OVERDOSAGE
Limited information is available on the acute toxicity of methocarbamol.
Overdose of methocarbamol is frequently in conjunction with alcohol or other CNS depressants and includes the following symptoms: nausea, drowsiness, blurred vision, hypotension, seizures, and coma.
In post-marketing experience, deaths have been reported with an overdose of methocarbamol alone or in the presence of other CNS depressants, alcohol or psychotropic drugs.
Treatment Management of overdose includes symptomatic and supportive treatment.
Supportive measures include maintenance of an adequate airway, monitoring urinary output and vital signs, and administration of intravenous fluids if necessary.
The usefulness of hemodialysis in managing overdose is unknown.
DESCRIPTION
Methocarbamol tablets USP a carbamate derivative of guaifenesin, is a central nervous system (CNS) depressant with sedative and musculoskeletal relaxant properties.
The chemical name of methocarbamol is 3-(2-methoxyphenoxy)-1,2-propanediol 1-carbamate and has the empirical formula C1111H1515NO55.
Its molecular weight is 241.24.
The structural formula is shown below.
Methocarbamol is a white powder, sparingly soluble in water and chloroform, soluble in alcohol (only with heating) and propylene glycol, and insoluble in benzene and n-hexane.
Methocarbamol tablets USP are available as 500 mg and 750 mg tablets for oral administration.
Methocarbamol tablets USP 500 mg and 750 mg contain the following inactive ingredients: sodium lauryl sulfate, sodium starch glycolate, povidone K 90, polyethylene glycol, magnesium stearate, colloidal silicon dioxide, low substituted hydroxypropyl cellulose and stearic acid.
structure.jpg
HOW SUPPLIED
Product: 50090-0183 NDC: 50090-0183-0 10 TABLET in a BOTTLE NDC: 50090-0183-2 7 TABLET in a BOTTLE NDC: 50090-0183-4 90 TABLET in a BOTTLE
INDICATIONS AND USAGE
INDICATIONS & USAGE Methocarbamol tablets USP are indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute, painful musculoskeletal conditions.
The mode of action of methocarbamol has not been clearly identified, but may be related to its sedative properties.
Methocarbamol does not directly relax tense skeletal muscles in man.
PEDIATRIC USE
Pediatric Use Safety and effectiveness of methocarbamol tablets USP in pediatric patients below the age of 16 have not been established.
PREGNANCY
Pregnancy Teratogenic effects -Pregnancy Category CTeratogenic effects -Pregnancy Category C Animal reproduction studies have not been conducted with methocarbamol.
It is also not known whether methocarbamol can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity.
Methocarbamol tablets USP should be given to a pregnant woman only if clearly needed.
Safe use of methocarbamol tablets USP has not been established with regard to possible adverse effects upon fetal development.
There have been reports of fetal and congenital abnormalities following in utero exposure to methocarbamol.
Therefore, methocarbamol tablets USP should not be used in women who are or may become pregnant and particularly during early pregnancy unless in the judgment of the physician the potential benefits outweigh the possible hazards (see WARNINGS see WARNINGSWARNINGS).
NUSRING MOTHERS
Nursing Mothers Methocarbamol and/or its metabolites are excreted in the milk of dogs; however, it is not known whether methocarbamol or its metabolites are excreted in human milk.
Because many drugs are excreted in human milk, caution should be exercised when methocarbamol tablets USP are administered to a nursing woman.
INFORMATION FOR PATIENTS
Information for Patients Patients should be cautioned that methocarbamol may cause drowsiness or dizziness, which may impair their ability to operate motor vehicles or machinery.
Because methocarbamol may possess a general CNS-depressant effect, patients should be cautioned about combined effects with alcohol and other CNS depressants.
DOSAGE AND ADMINISTRATION
DOSAGE & ADMINISTRATION Methocarbamol Tablets USP 500 mg – Adults: Initial dosage: 3 tablets q.i.d.
Maintenance dosage: 2 tablets q.i.d.
Methocarbamol Tablets USP 750 mg – Adults: Initial dosage: 2 tablets q.i.d.
Maintenance dosage: 1 tablet q.4h.
or 2 tablets t.i.d.
Six grams a day are recommended for the first 48 to 72 hours of treatment.
(For severe conditions 8 grams a day may be administered).
Thereafter, the dosage can usually be reduced to approximately 4 grams a day.